Project Manager Clinical Operations (f/m/x)

at  ZEISS Group

Carl Zeiss Meditec AG enables medical professionals worldwide to improve the lives of their patients in ophthalmology, microsurgery and other medical growth sectors. With our proven medical technology and application expertise, we are driving standards of care. Together with our colleagues in locations around the world, we work every day to achieve this goal.
This position can be held in Berlin, Munich, Jena or Oberkochen.
Your role:

Planning, implementation and management of international clinical studies with medical devices (primarily Intraocular Lenses, IOLs) according to applicable regulations and guidelines:

• Development of strategies and designs of clinical studies in cooperation with internal and external partners e.g., Contract Research Organizations (CROs)
• Creation of study-relevant documents that are necessary for regulatory approvals and their submission to responsible authorities and ethics committees.
• Ensuring the smooth running of the study projects by interacting with the study sites and acting as the central interface for the project stakeholders on a global scale
• Monitoring of the study status and CRO activities
• Reporting and presentations on the status as well as evaluation of the study results

Contribution to process development and evaluation of new regulations, guidelines, and standards for clinical studies.

Your profile:

• College/university degree in optometry/opthalmology, medicine, medical technology or natural sciences
• Several years of experience in clinical affairs/clinical research project management in the medical device/ pharma industry or with CROs
• Good knowledge of relevant regulatory requirements for clinical studies for medical devices and experience in planning and conducting clinical studies
• Strong analytical skills coupled with creativity and intuition
• Commitment and creative drive as well as strong communication and organizational skills in an international environment
• Business fluent English and German skills, both spoken and written
• Willingness to travel worldwide

Your ZEISS Recruiting Team:
Nicole Kraft-Henzelman

Please refer the Job description for details